Label: ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 63941-003-77, 63941-003-86
- Packager: Valu Merchandisers Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Do Not use
- Stop use and ask a dentist
- Keep out of reach of Children
- Directions
- Other information
- Inactive ingredients
- Questions
- Disclaimer
- Adverse Reaction
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principal display panel
Best
Choice
Sealed With Printed Neckband For Your Protection
COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE**
ANTISEPTIC
Mouth Rinse
ANTIGINGIVITIS/ANTIPLAQUE
ADA
Accepted
American Dental Association
- Helps reduce plaque
- Helps reduce gingivitis
Kills Germs That Cause Bad Breath, Plaque & Gingivitis Gum Disease
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.60 mg in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) BENZOIC ACID (UNII: 8SKN0B0MIM) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-003-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/09/1995 2 NDC:63941-003-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/09/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/09/1995 Labeler - Valu Merchandisers Co (868703513) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63941-003) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63941-003)